|
Device | Valiant Navion Thoracic Stent Graft System |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P100040 |
Supplement Number | S036 |
Date Received | 04/23/2018 |
Decision Date | 10/19/2018 |
Product Code |
MIH |
Docket Number | 18M-4033 |
Notice Date | 10/25/2018 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT02625324
|
Supplement Type | Panel Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval of the Valiant Navion Thoracic Stent Graft System, a modified device design from the Valiant Thoracic Stent Graft with Captivia Delivery System. This device is indicated for all lesions of the descending thoracic aorta (DTA) in patients having appropriate anatomy: 1) iliac or femoral artery access vessel morphology that is compatible with vascular access techniques, devices, or accessories;2) nonaneurysmal aortic diameter in the range of: 16 mm to 42 mm for fusiform and saccular aneurysms/penetrating ulcers, 16 mm to 44 mm for blunt traumatic aortic injuries, 19 mm to 45 mm for dissections; 3) proximal landing zone (nonaneurysmal aortic proximal neck length for fusiform and saccular aneurysms/penetrating ulcers or nondissected length of aorta proximal to the primary tear for blunt traumatic aortic injuries and dissections) of: >= 20mm for FreeFlo configuration and ?>=25mm for CoveredSeal configuration; and 4) nonaneurysmal aortic distal neck length >= 20mm for FreeFlo and CoveredSeal configurations for fusiform and saccular aneurysms/penetrating ulcers. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |